Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 3:18 AM
Study NCT ID:
NCT06929156
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t)'}, {'measure': 'Maximum Concentration of BGM0504 (Cmax)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Maximum Concentration of BGM0504 (Cmax)'}, {'measure': 'Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf)'}], 'secondaryOutcomes': [{'measure': 'Time to maximum concentration (Tmax)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Time to maximum concentration (Tmax)'}, {'measure': 'Apparent terminal half-life (t1/2)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Apparent terminal half-life (t1/2)'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'Start of Treatment up to Day 29', 'description': 'Apparent clearance (CL/F)'}, {'measure': 'Incidence and severity of adverse events', 'timeFrame': 'Screening period up to Day 29', 'description': 'Incidence and severity of adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Overweight or Obese']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* √ Age 18-65 years on the date of signing informed consent (inclusive);\n\n * Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.\n * Stable renal function, assessed by two eGFR during screening (apart at least 3 days);\n * Diagnosed as stable, chronic renal disease for at least 3 months.\n * Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):\n\n 1. Normal renal function: 90-129 mL/min (inclusive);\n 2. Mild impairment: 60-89 mL/min (inclusive);\n 3. Moderate impairment: 30-59 mL/min (inclusive);\n 4. Severe impairment: 15-29 mL/min (inclusive);\n\nExclusion Criteria:\n\n* ● Allergic constitution includes severe drug allergy or history of drug allergy;\n\n * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; Have a history or presence of pancreatitis;\n * Participants in clinical trials of any drug or medical device in the 3 months prior to screening;.\n * Suspected or confirmed history of alcohol or drug abuse;\n * Hepatitis B surface antigen (HBsAg), HIV antibody detection, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive;\n * Donation or loss of 200 mL or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial;\n * Pregnant or Breast-feeding women;\n * The investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06929156', 'briefTitle': 'A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrightGene Bio-Medical Technology Co., Ltd.'}, 'officialTitle': 'A Multi-center, Single-dose, Open-label, Parallel Design, Pharmacokinetics Study of BGM0504 Injection in Healthy Participants and Participants With Impaired Renal Function', 'orgStudyIdInfo': {'id': 'BGM0504-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group (Healthy Control)', 'interventionNames': ['Drug: BGM0504']}, {'type': 'EXPERIMENTAL', 'label': 'B group (Mild Renal Impairment)', 'interventionNames': ['Drug: BGM0504']}, {'type': 'EXPERIMENTAL', 'label': 'C group (Moderate Renal Impairment)', 'interventionNames': ['Drug: BGM0504']}, {'type': 'EXPERIMENTAL', 'label': 'D group (Severe Renal Impairment)', 'interventionNames': ['Drug: BGM0504']}], 'interventions': [{'name': 'BGM0504', 'type': 'DRUG', 'description': 'Receive a single dose of BGM0504 injection', 'armGroupLabels': ['A group (Healthy Control)']}, {'name': 'BGM0504', 'type': 'DRUG', 'description': 'Receive a single dose of BGM0504 injection', 'armGroupLabels': ['B group (Mild Renal Impairment)']}, {'name': 'BGM0504', 'type': 'DRUG', 'description': 'Receive a single dose of BGM0504 injection', 'armGroupLabels': ['C group (Moderate Renal Impairment)']}, {'name': 'BGM0504', 'type': 'DRUG', 'description': 'Receive a single dose of BGM0504 injection', 'armGroupLabels': ['D group (Severe Renal Impairment)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650100', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Zhao', 'role': 'CONTACT', 'email': 'Zhao4wei2@hotmail.com', 'phone': '860531-82921552'}], 'facility': 'The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wei Zhao', 'role': 'CONTACT', 'email': 'Zhao4wei2@hotmail.com', 'phone': '860531-82921552'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrightGene Bio-Medical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}